Showing posts with label Pharmaceuticals (TRBC). Show all posts
Showing posts with label Pharmaceuticals (TRBC). Show all posts

Friday, June 14, 2019

Pharmacies may not stock naloxone, despite statewide orders

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(Reuters Health) - More than three years after Pennsylvania issued a statewide order expanding access to the life-saving opioid antidote naloxone, the product was still hard to purchase in Philadelphia pharmacies, researchers found.

In 2017, two-thirds of pharmacies in Philadelphia either did not stock naloxone, or they still insisted on a physician’s prescription, which the law said was no longer required.

In the wake of the opioid addiction crisis that has claimed thousands of lives, many U.S. states have passed laws like Pennsylvania’s, which allow the drug to be dispensed without a prescription and mandate that every drugstore carry it.

Laws that let pharmacists sell naloxone without prescription have been associated with a nearly 30% drop in the number of opioid overdose deaths, a separate team of researchers reported last month. (reut.rs/2WM3qMa)

Yet this study is not the first to find that drugstores are slow to comply. Research has shown that most pharmacies in California and Texas, for example, do not carry the drug or make it readily available.

The new results add to the growing body of evidence that these laws are not being enforced, experts said.

“While policy can be put in place, it’s not sufficient and has to be followed up with education, and reinforcement at the county and pharmacy level, and not just assume that the policy itself will ensure access to anyone who needs it,” Dr. Michael Lynch, a toxicologist and emergency medicine physician who was not involved in the study, told Reuters Health.

For the current study, Dima Qato of the University of Illinois, Chicago and colleagues contacted 418 drugstores in Philadelphia between February and August 2017 and found that only about 34% had naloxone in stock - and 38.5% of those drugstores required a physician’s prescription to dispense the drug.

People living in communities with elevated rates of opioid overdose deaths were the least likely to have access to naloxone without a prescription and had to pay more to buy the drug, the researchers wrote in JAMA Network Open.

“Areas that need this policy enforced the most are areas that lack it and that’s a concern,” Qato told Reuters Health by phone.

An overdose of opioids like morphine or heroin slows breathing, reducing the supply of oxygen to the body. Naloxone helps reverse the effects of an overdose and saves lives.

Lynch, who is also the medical director of the Pittsburgh Poison Center at the University of Pittsburgh Medical Center, notes that the high importance of naloxone may not necessarily translate to high demand.

“If patients or individuals are not coming in and asking for it, pharmacies, especially a local independent pharmacy with pretty narrow margins, may not continue to stock a medication that isn’t being dispensed,” he added.

However, Mel Brodsky, executive director of PARD, an association of community pharmacies in Philadelphia, disputes the study’s findings.

“It is from 2 years ago - a lot has changed. Philadelphia mandates that every pharmacy have 2 doses of naloxone in stock. As I travel to my stores, I see 95% having naloxone in stock,” he told Reuters Health by email.

Dr. Michael Fingerhood, of Johns Hopkins Bayview Medical Center in Baltimore, Maryland, told Reuters Health that the low numbers in the study may be partly due to a shortage of naloxone in 2017.

“I would do a similar study now, (when) we don’t have a shortage of naloxone, and see if there has been any difference, two years later,” he said.

SOURCE: bit.ly/2IEd5LZ JAMA Network Open, online June 7, 2019

Our Standards:The Thomson Reuters Trust Principles.


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Enanta's lung infection therapy succeeds in mid-stage trial

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(Reuters) - Enanta Pharmaceuticals Inc said on Friday its treatment for a highly contagious respiratory infection met the main goal of reducing virus levels in the body and improving symptoms in patients in a mid-stage study.

The therapy, EDP-938, developed for treating respiratory syncytial virus (RSV) infection which currently has no available treatment, was compared with placebo, the company said.

RSV could lead to serious lung infections and even death in babies and the elderly who have a weaker immune system.

An average of 57,527 children younger than 5 years and 177,000 adults older than 65 years are hospitalized due to RSV infections every year, according to the Centers for Disease Control and Prevention.

Enanta said study results showed its therapy was generally safe and well tolerated and no drug discontinuations were observed.

Drugmakers Regeneron Pharmaceuticals Inc and Johnson & Johnson have abandoned their programs to find a treatment for the condition, and an experimental vaccine developed by Novavax Inc had failed a late-stage trial, earlier this year.

Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shinjini Ganguli

Our Standards:The Thomson Reuters Trust Principles.


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Thursday, June 13, 2019

IBM, Walmart, Merck in blockchain collaboration with FDA

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FILE PHOTO: The Walmart logo in New York, U.S., May 1, 2018. REUTERS/Brendan McDermid/File Photo

(Reuters) - IBM, Merck and Walmart have been chosen for a U.S. Food and Drug Administration pilot program that will explore using blockchain technology to improve the security of prescription drug supply and distribution.

The companies said they would work with consultancy KPMG to create a shared blockchain network that will allow real-time monitoring of products in the pharmaceutical supply chain.

The project has been authorized under the U.S. Drug Supply Chain Security Act (DSCSA) that was set up to increase regulatory oversight of counterfeit, stolen, contaminated or otherwise harmful drugs.

The FDA has previously used the DSCSA to issue a warning letter to drug distributor McKesson Corp for violations involving opioid medications.

Opioids have been tied to thousands of overdose deaths and state and local governments across the United States have filed lawsuits seeking to hold pharmaceutical companies responsible for the epidemic of abuse.

The new project is aimed at reducing the time needed to track and trace prescription drugs, improving access to reliable distribution information and ensuring products are handled appropriately and stored at the right temperature while being distributed, the companies said in a statement.

Blockchain technology, originally conceived a decade ago as the basis for the cryptocurrency bitcoin, will help stakeholders establish a permanent record and can be integrated with existing systems used to trace products while they are distributed.

The project is scheduled to be completed in the fourth quarter of 2019 and results will be published in a report, the companies said.

Reporting by Tamara Mathias in Bengaluru; Editing by Shinjini Ganguli

Our Standards:The Thomson Reuters Trust Principles.


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Wednesday, June 12, 2019

Canadian panel calls for universal public drug coverage

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OTTAWA/TORONTO (Reuters) - A Canadian advisory council studying prescription drug coverage said on Wednesday the federal government should create a C$15.3 billion ($11.5 billion) universal, single-payer public pharmacare system, and warned that the current system requires a major overhaul.

A pharmacist counts prescription drugs at the at the CentreTown Pharmacy in Ottawa, Ontario, Canada, June 12, 2019. REUTERS/Chris Wattie

The council said the plan should be implemented no later than Jan. 1, 2027, with coverage for essential medicines in place by Jan. 1, 2022.

Canada is the only country with a universal health care system that does not include universal coverage for prescription drugs. Most prescriptions are paid for through employer-funded drug plans, while some are covered by government programs for the elderly, or people with low incomes or very high costs.

“We can’t tinker with what exists. We have to transform it,” council chair Eric Hoskins, a former Ontario health minister, said at a news conference.

The report said public and private drug providers had told the council the system is “near the breaking point.”

Canadian Prime Minister Justin Trudeau’s Liberal government has promised some kind of national pharmacare program, and its approach may be a key issue in the country’s October election.

Minister of Health Ginette Petitpas Taylor said in a statement that the government would “carefully study” the recommendations “over the coming months.”

The council estimated the national pharmacare would cost the federal government an additional C$3.5 billion at its launch in 2022, and C$15.3 billion in 2027.

If implemented in full, the plan would likely cut into profits of insurers and drugmakers in Canada, while saving employers and patients money.

Shares of three major insurers listed in Canada, Manulife Financial Corp, Sun Life Financial Inc and Great-West Lifeco Inc, all dropped.

‘SPACE’ FOR THE PRIVATE SECTOR

Canada’s drug insurance system is a patchwork of more than 1,000 public and 100,000 private plans, which can make it difficult for smaller payers to negotiate discounts with pharmaceutical companies.

The Canadian Life and Health Insurance Association (CLHIA)urged the government to work with private plans to negotiate lower drug prices. CLHIA president Stephen Frank said in a statement that all Canadians can have access to the medications they need “without putting at risk what’s working today.”

Hoskins said costs associated with the proposed program are already being paid by Canadians. By 2027, total prescription drug spending would be about 10% lower with the proposed changes, Hoskins said. Canadians spent C$34 billion ($25.6 billion) on prescription medicines in 2018.

Hoskins said he envisions “space” for the private drug insurance sector after a universal public program is rolled out.

“The profit that insurance companies generate through drug insurance plans is modest, I would describe it, compared to other aspects of benefits provided,” he said.

Pamela Fralick, president of pharmaceutical industry group Innovative Medicines Canada, said whatever path the government chooses, “no Canadian should be worse off than they are right now.”

NEW DRUG PRICE RULES IN THE WORKS

Speaking after the report’s release, Petitpas Taylor said work on the Canadian government’s proposal to reduce patented drug prices is still underway, and “movement” would come in the very near future.

New regulations, set to go into effect in January 2019, were delayed amid heavy lobbying from drugmakers.

Slideshow (3 Images)

Patented drug prices in Canada are among the highest in the world. Government surveys show some 20% of Canadians are uninsured or under-insured.

In its most recent budget the Trudeau government promised modest changes, including new funds for expensive drugs that treat rare diseases.

Reporting by Kelsey Johnson in Ottawa and Allison Martell in Toronto; Editing by Bill Berkrot

Our Standards:The Thomson Reuters Trust Principles.


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